Ezetimibe NDC 63629-7413

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-7413Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-7413Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
63629-7413-1	63629741301	30 TABLET in 1 BOTTLE (63629-7413-1)Marketed from Oct 10, 2017
63629-7413-2	63629741302	90 TABLET in 1 BOTTLE (63629-7413-2)Marketed from Oct 10, 2017
63629-7413-3	63629741303	28 TABLET in 1 BOTTLE (63629-7413-3)Marketed from Apr 3, 2024
63629-7413-4	63629741304	18 TABLET in 1 BOTTLE (63629-7413-4)Marketed from Apr 3, 2024
63629-7413-5	63629741305	60 TABLET in 1 BOTTLE (63629-7413-5)Marketed from Apr 3, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Ezetimibe
Generic name (nonproprietary): ezetimibe
Active ingredients: Ezetimibe — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203931
Marketing start: Jun 12, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 63629-7413_359e02cb-5fc3-494a-9bf8-d2578aae8ee8SPL ID 359e02cb-5fc3-494a-9bf8-d2578aae8ee8SPL set ID 03609879-bad2-4e75-83fe-1e1a2fd300c3RxCUI 349556UNII EOR26LQQ24
Pharmacologic class: Dietary Cholesterol Absorption Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463629741301 followed by a unit qualifier and the quantity

Package 63629-7413-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 3, 2024.

Indications (excerpt from the label)

Ezetimibe is indicated: • In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). • In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. • In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. • In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)